Anders - Whats with that? If the FDA does not allow anavex to start the Rett trial on or before Jan 31 then the rest of the year is a dead end too? How does that work? So much for a more cooperative 21st Century Cures Act?
Why ?
I believe anything thats doesn't start soon the results and ultimate approval won't happen in 2018. I've been long here for several years and quite frankly, my (and other's) optimism has not panned out. I can not think of one situation (while being invested in AVXL) that something happen early or even on-time. I am still very positive on A2-73 being approved, however, the progressive always seem to have undiagnosed set backs.
As this relates to the 21CCA, once the trial begins I believe the 21CCA will apply. However, it seems like there are more obstacles to this trial starting then was anticipated. Once we start we should be golden.
I have developed a bald spot from scratching my head trying to comprehend and diagnosis why we have all the delays. Nothing is perfect here so I expect there will be future unknown delaying the ultimate outcome. Outcome is defined as approval.
If what I stated in my previous post is true for the Rett delay and the PD move to EU, then it may also be true we will have future unexpected delays. I seriously doubt the good Doc expected the FDA was going to hold off on the PD trials here in the US. I seriously doubt the intent all along was to run it in the EU since the testing was done in Sweden. One thing about Missling that is indisputable, is that he relishes in independent studies. In light of that, I dont think he would involve the testing facility host the trials. He would choose another independent entity to confirm. Just as he did with MS. He didn't leave it just to BIIB. Having WSU independently test what BIIB was testing was smart. He now knows what BIIB knows. he just improved his leveraging with a MS with BIIB and thus the long silence. Bigger deals take longer time.
I hope I explained my position. Im not negative its just I've seen too many delays and disappointments along this bumpy road and I expect the road to remain bumpy.
I dont know if my theory is true, however since Missling is not so forthwith with details, it leaves me with no option but to ascertain what may have happen. I tried to approach as to why we dont have 3 trials starting from a neutral position (although I am very long). So far, I believe my explanation makes sense. We will never know.
